Pharma R&D Microbiologist: Method Development

6AM City, LLC; Kansas; On-site; USD 70,000 - 110,000; Full time

Job summary

6AM City, LLC is seeking a Microbiologist to support pharmaceutical method development and quality control in a QC laboratory in Kansas. You will develop, evaluate, and validate compendial microbiology methods for sterile injections, non-sterile suspensions, and veterinary solid dosage forms, collaborating with QC teams and external customers.

The role requires 4+ years in pharmaceutical QC under cGMP and hands-on experience with sterility, endotoxin, and microbial limits testing, as well as

Qualifications

• Bachelor's degree in microbiology or related field is required.
• 4+ years in pharmaceutical QC role under cGMP (FDA 21 CFR 210/211).
• Hands-on method development and validation experience with compendial microbiology methods.
• Experience performing sterility testing per USP <71> and isolator use preferred.
• Experience with endotoxin testing per USP <85> and kinetic chromogenic/turbidimetric methods.
• Experience with Microbial Limits Testing per USP <61> and <62>.
• Experience with subvisible particulate testing per USP <788>.
• Proficiency in media growth promotion testing and microbial identification.
• Maintaining aseptic technique and contamination control in QC labs.

Responsibilities

• Perform method feasibility, development, and validation for compendial microbiology methods.
• Develop and validate microbiological methods for multiple product types and APIs.
• Author, execute, and review validation reports in line with SOPs.
• Conduct sterility testing per USP <71> including isolator-based testing where applicable.
• Perform endotoxin testing per USP <85> with validated methods.
• Execute Microbial Limits Testing per USP <61> and <62> for various matrices.
• Conduct subvisible particulate testing per USP <788> using appropriate methods.
• Apply aseptic technique and cell culture practices to support assays.
• Collaborate with QC team, project teams, and external customers on method transfer.

Skills

Sterility testing

Endotoxin testing

Microbial limits testing

Subvisible particulate testing

Media growth promotion

Microbial identification

Aseptic technique

cGMP compliance

FDA 21 CFR 210/211 knowledge

Education

Bachelor's degree in microbiology

Tools

Isolators

Job description

6AM City, LLC is seeking a Microbiologist to support pharmaceutical method development and quality control in a QC laboratory in Kansas. You will develop, evaluate, and validate compendial microbiology methods for sterile injections, non-sterile suspensions, and veterinary solid dosage forms, collaborating with QC teams and external customers.

The role requires 4+ years in pharmaceutical QC under cGMP and hands-on experience with sterility, endotoxin, and microbial limits testing, as well as